Updating the European Pharmacopoeia impurity profiling method for terazosin and suggesting alternative columns.

Journal of Pharmaceutical and Biomedical Analysis(2020)

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摘要
•A new (U)HPLC method was developed for terazosin impurity profiling to update the Ph. Eur. Method.•A generic workflow has been proposed to suggest replacement columns for a given separation.•Column comparison was based on the visualization and overlay of design spaces.•The new method was validated in accordance with international guidelines.
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关键词
Column comparison,Design of experiments,Method validation,Quality by design,Robustness,Terazosin
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